Clinical Trial Results:
Phase II, randomised, multicentre study with two treatment arms (R-COMP versus R-CHOP) in newly diagnosed elderly patients (?60 years) with non-localised diffuse large B-cell lymphoma (DLBCL)/follicular lymphoma grade IIIb.
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Summary
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EudraCT number |
2013-001065-17 |
Trial protocol |
ES |
Global end of trial date |
17 Feb 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
02 Jul 2021
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First version publication date |
02 Jul 2021
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
GEL-R-COMP-2013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02012088 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
GELTAMO
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Sponsor organisation address |
AVENIDA VALDECILLA, SANTANDER, Spain,
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Public contact |
GELTAMO, Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea, 0034 913195780, dm@geltamo.com
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Scientific contact |
GELTAMO, Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea, 0034 913195780, sc@geltamo.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Feb 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Feb 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
?To assess reduced of subclinical cardiotoxicity, determined by differences in LVEF, which involves the incorporation of non-pegylated liposomal doxorubicin (Myocet®) when replacing conventional doxorubicin in the standard R-CHOP regimen (R-COMP) to treat newly diagnosed elderly patients with non-localised DLBCL/follicular lymohoma grade IIIb
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Protection of trial subjects |
Several strategies have been proposed to decrease cardiotoxicity provoked by anthracyclines in elderly populations.
These include the administration of reduced doses or slow
infusions of doxorubicin, use of cardioprotective agents or
substitution by other antineoplastic agents or by other less
cardiotoxic anthacyclines, such as mitoxantrone, epirubicin,
or liposomal formulations of doxorubicin.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
31 Aug 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 90
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Worldwide total number of subjects |
90
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EEA total number of subjects |
90
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
45
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From 65 to 84 years |
45
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85 years and over |
0
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Recruitment
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Recruitment details |
The requirements for the patients to be included were: age 60 years, newly diagnosed non-localized DLBCL or grade 3b FL (those with localized lymphoma were included in the presence of bulky disease) | |||||||||
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Pre-assignment
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Screening details |
- | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
90 | |||||||||
Number of subjects completed |
90 | |||||||||
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Period 1
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Period 1 title |
OVERALL TRIAL (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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R-CHOP arm | |||||||||
Arm description |
to receive R-CHOP (rituximab 375 mg/m2 [day 1], cyclophosphamide 750 mg/m2 [day 1], doxorubicin 50 mg/m2 [day 1], vincristine 1.4 mg/m2 [day 1, capped at a maximum of 2 mg], and prednisone 60mg/m2 [days 1–5] | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
R-CHOP doxorubicin vincristine cyclophosphamid
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
Patients were randomized 1:1 to receive R-CHOP (rituximab
375 mg/m2
[day 1], cyclophosphamide 750 mg/m2
[day 1],
doxorubicin 50 mg/m2
[day 1], vincristine 1.4 mg/m2
[day 1,
capped at a maximum of 2 mg], and prednisone 60mg/m2
[days
1–5]) o
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Arm title
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R-COMP arm | |||||||||
Arm description |
R-COMP (with the same drugs except for conventional doxorubicin being replaced by non-pegylated liposomal doxorubicin, Myocet®, at doses of 50 mg/m2 [day 1in both arms every 21 days for a total of six cycles | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
R-COMP Myocet®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate and solvent for solution for injection/infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
R-COMP (with the same drugs used in R-chop except for conventional
doxorubicin being replaced by non-pegylated liposomal doxorubicin, Myocet®, at doses of 50 mg/m2
[day 1])
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Baseline characteristics reporting groups
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Reporting group title |
OVERALL TRIAL
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
All
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
a clinical trial for patients 60 years old diagnosed with DLBCL
or grade 3b follicular lymphoma (FL) with normal cardiac
function, with the main objective of evaluating the possible
benefits in terms of cardiac toxicity, of the substitution of
conventional doxorubicin by non-pegylated liposomal doxorubicin (Myocet®, R-COMP arm) as part of R-CHOP therap
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End points reporting groups
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Reporting group title |
R-CHOP arm
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Reporting group description |
to receive R-CHOP (rituximab 375 mg/m2 [day 1], cyclophosphamide 750 mg/m2 [day 1], doxorubicin 50 mg/m2 [day 1], vincristine 1.4 mg/m2 [day 1, capped at a maximum of 2 mg], and prednisone 60mg/m2 [days 1–5] | ||
Reporting group title |
R-COMP arm
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Reporting group description |
R-COMP (with the same drugs except for conventional doxorubicin being replaced by non-pegylated liposomal doxorubicin, Myocet®, at doses of 50 mg/m2 [day 1in both arms every 21 days for a total of six cycles | ||
Subject analysis set title |
All
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
a clinical trial for patients 60 years old diagnosed with DLBCL
or grade 3b follicular lymphoma (FL) with normal cardiac
function, with the main objective of evaluating the possible
benefits in terms of cardiac toxicity, of the substitution of
conventional doxorubicin by non-pegylated liposomal doxorubicin (Myocet®, R-COMP arm) as part of R-CHOP therap
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End point title |
Primary | ||||||||||||
End point description |
The primary end point of the study was to evaluate the differences
in subclinical cardiotoxicity, defined by a decrease in LVEF to
<55% at the end of treatment (measured by echocardiography
at 1 month after therapy), in patients receiving the standard
R-CHOP regimen compared with those treated with R-COMP
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End point type |
Primary
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End point timeframe |
Subclinical cardiac toxicity determined by the percentage of measurings experiencing a decrease in LEVF
determined by echocardiography with final LEVF <55% 30 and/or 120 days after the end of the study treatment
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Statistical analysis title |
Complete analisis | ||||||||||||
Comparison groups |
R-CHOP arm v R-COMP arm
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Number of subjects included in analysis |
90
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Analysis specification |
Post-hoc
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Analysis type |
other | ||||||||||||
P-value |
< 5 | ||||||||||||
Method |
No imputation method | ||||||||||||
Confidence interval |
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End point title |
Secondary | |||||||||
End point description |
Secondary end points were efficacy in terms of overall
and complete response rates (ORR and CR) in all randomized
patients, event-free survival (EFS), progression-free survival
(PFS), overall survival (OS), and safety. Response to treatment was evaluated according to clinical, laboratory results
and the evaluation of imaging techniques according to the
criteria defined by Cheson et al.2
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End point type |
Secondary
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End point timeframe |
30 and 120 days after the end of the study treatment
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
assessment of adverse events (AE) using version 4.0 of the NCI-CTCAE scale for grading toxicity, as
well as the variations in cardiac biomarkers troponin and NTproBNP in both arms throughout the study
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
NCI-CTCAE | ||||||||||||||||||||||||||||||
Dictionary version |
4
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Reporting groups
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Reporting group title |
Non-hematologic toxicity
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Reporting group description |
- | ||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
